Prescription medicine
Insulin degludec Brand names: Tresiba
Insulin degludec (Tresiba) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $11.39 per mL (Insulin degludec flextouch 100 unit/mL pen) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the insulin degludec FDA label on DailyMed (effective July 1, 2022, Novo Nordisk Pharma, Inc.); the BLA 203314 record on Drugs@FDA; every insulin degludec label on DailyMed.
Highlights of the record
FDA label of July 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageInsulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- September 25, 2015 Tresiba, Novo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $11.39 per mL Insulin degludec flextouch 100 unit/mL pen
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2021 3 Class I among all firms' recalls; latest March 22, 2021
- FAERS reports
- 23,334 through July 30, 2026
What is insulin degludec used for?
From the label: indications and usageInsulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use
Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis.
Conditions named in the indications of insulin degludec's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Insulin Analog.
Source: FDA drug label (Insulin Degludec), Novo Nordisk Pharma, Inc., effective July 1, 2022 (SPL set c1be283d-4b1d-4996-b2a7-4488dbff3037), via openFDA; the full label on DailyMed
What does the patient leaflet for insulin degludec say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking Insulin Degludec?While taking Insulin Degludec do not: • Drive or operate heavy machinery, until you know how Insulin Degludec affects you. • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
Source: FDA drug label (Insulin Degludec), Novo Nordisk Pharma, Inc., effective July 1, 2022 (SPL set c1be283d-4b1d-4996-b2a7-4488dbff3037), via openFDA; the full label on DailyMed
Is there a generic for insulin degludec (Tresiba)?
No generic insulin degludec is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for insulin degludec (Tresiba)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.39 per mL (Insulin degludec flextouch 100 unit/mL pen), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Insulin degludec 100 unit/mL vial (generic)
- Tresiba 100 unit/mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Insulin degludec 100 unit/mL vial | Generic | $11.34 per mL | n/a | -0.2% |
| Insulin degludec flextouch 100 unit/mL pen | Generic | $11.39 per mL | n/a | +0.1% |
| Insulin degludec flextouch 200 unit/mL pen | Generic | $22.74 per mL | n/a | no change |
| Tresiba 100 unit/mL vial | Brand | $9.02 per mL | n/a | -72% |
| Tresiba flextouch 100 unit/mL | Brand | $9.04 per mL | n/a | -72% |
| Tresiba flextouch 200 unit/mL | Brand | $18.07 per mL | n/a | -72% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has insulin degludec been recalled?
The FDA's Enforcement Report lists 3 recalls naming insulin degludec since 2021: 3 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 22, 2021 | Class I | Novo Nordisk Inc | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the insulin degludec label say about other medicines?
The insulin degludec label names 17 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when Insulin Degludec is co-administered with these drugs. |
| Clonidine | drug interactions | Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. |
| Clozapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Danazol | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Disopyramide | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 … |
| Epinephrine | drug interactions | … (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when Insulin Degludec is co-administered with these drugs. |
| Fluoxetine | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 … |
| Glucagon | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Isoniazid | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Lithium | drug interactions | Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. |
| Niacin | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Octreotide | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 … |
| Olanzapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease … |
| Pentoxifylline | drug interactions | Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 … |
Every other medicine the insulin degludec label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pramlintide | drug interactions | … fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 … |
| Somatropin | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. … |
| Terbutaline | drug interactions | … somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when … |
Source: FDA drug label (Insulin Degludec), Novo Nordisk Pharma, Inc., effective July 1, 2022 (SPL set c1be283d-4b1d-4996-b2a7-4488dbff3037), via openFDA; the full label on DailyMed
What do FAERS reports show for insulin degludec?
The FDA Adverse Event Reporting System holds 23,334 reports that list insulin degludec among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,281 are coded as a death and 6,810 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as insulin degludec?
13 other medicines are given the same way (subcutaneous) and in the same FDA class as insulin degludec or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Insulin glargine | Type 2 diabetes, Type 1 diabetes | none listed | $2.90 per mL 100 pen | A presentation being discontinued |
| Insulin aspart | Type 2 diabetes, Type 1 diabetes | none listed | $6.95 per mL 100 unit/mL vial | No current entry |
| Insulin lispro | Type 2 diabetes, Type 1 diabetes | none listed | $10.19 per mL 100 unit/mL kwikpen | A presentation being discontinued |
| Insulin detemir | Type 2 diabetes, Type 1 diabetes | none listed | n/a | No current entry |
| Insulin glulisine | Type 2 diabetes, Type 1 diabetes | none listed | $8.16 per mL 100 unit/mL vial | No current entry |
| Insulin glargine and lixisenatide | Type 2 diabetes | none listed | $57.06 per mL 100 unit-33 mcg/mL pen | No current entry |
| Tirzepatide | Type 2 diabetes | none listed | $538.68 per mL 10 mg/0.5 mL pen | No current entry |
| Liraglutide | Type 2 diabetes | 9 labelers | $31.41 per mL 2-pak 18 mg/3 mL | In shortage |
Every medicine labeled for the same conditions as insulin degludec
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does insulin degludec compare with medicines for the same use?
1 side-by-side page set insulin degludec beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to insulin degludec
- 13 medicines for the same use
- Other insulin analogs
- the pharmacologic class, with prices and generics
- Insulin degludec side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other